A 52-Week Multicenter, Open-Label, Randomized, Parallel, Two - Arm Study Comparing Exubera® (Inhaled Human Insulin) Vs. Humalog® (Insulin Lispro), Both In Combination With Insulin Glargine In Subjects With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)
研究概览
简要总结
To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus
详细描述
Pfizer announced in October 2007 that it would stop marketing Exubera®. At that time recruitment for study, A2171035 was placed on hold. Nektar, the company from which Pfizer licensed Exubera®, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera®. As a result, study A2171035 was terminated on May 12, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus Type 1
排除标准
- •Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
研究组 & 干预措施
Control
干预措施: Insulin lispro (Humalog) (Drug)
Experimental
干预措施: Inhaled Human Insulin (Exubera®) (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)
时间窗: At 52 weeks
As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.
次要结局
- Change From Baseline in Post-prandial Blood Glucose Based on Glucometer Data and In-hospital Assessments(To 52 weeks)
- Change From Baseline in Insulin Antibody Levels(At weeks 24 and 52 or last observation.)
- Change From Baseline in Body Weight(At weeks 12, 24, 36, and 52 or last observation.)
- Change From Baseline in Body Mass Index(At weeks 12, 24, 36, and 52 or last observation.)
- Change From Baseline in Basal Insulin Doses(To 52 weeks)
- Change From Baseline in Prandial Insulin Doses(To 52 weeks)
- Blood Glucose Values From Baseline Determined by Home-monitored Blood Glucose (Subject Recorded Worksheet Values)(To 52 weeks.)
- Change in Fasting Lipids From Baseline(At weeks 24 and 52 or last observation)
- Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%(At 52 weeks)
- Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%(At 52 weeks)
- Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline(At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.)
- Change From Baseline in FPG(At 52 weeks or last observation)
- Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments(To 52 weeks)